Rep. Tom Cole (R-OK) Discusses the Cole-Bishop Amendment with Nicopure Labsjwyland
The Cole-Bishop Amendment has been a key player in the ongoing battle between the FDA and the vaping industry. What started as just a general disagreement against FDA regulations, quickly became an amendment sponsored by Rep. Tom Cole (R-OK) and Rep. Sanford Bishop (D-GA). Together, they have formed a movement to keep vaping products on the market for adult consumers.
“Before the amendment was created I didn’t know a lot about the vaping industry, but I was bothered by the idea of the FDA going back to 2007 for approval on vaping products,” said Rep. Tom Cole. “It’s like regulating through the review mirror and retroactively. To me, that did not seem fair to any business on any kind of regulation. I began to learn how many people the vaping industry had helped kick tobacco. I looked at the medical evidence, which was a considerable amount, and it’s much safer than smoking cigarettes or cigars. I began to wonder why the FDA was making it more difficult for these people.”
As Congressman Cole became involved with the legislation, he began to work closely with Congressman Bishop and made the amendment a bi-partisan effort. They spoke with vapers and vape shop owners and began to realize that the FDA’s regulations were not a productive way to move forward.
“The entire regulatory approach the FDA is taking toward both premium cigars and vaping has been punitive, and counterproductive. You don’t want to drive people out of business when they are selling a perfectly lawful product that helps people get out of the business of smoking,” said Congressman Cole. “There is a legitimate role for tobacco regulations, but vaping is not a tobacco product. The FDA is punishing an industry that does not need to be punished at all. They are creating barriers for customers and entrepreneurs with no evidence to justify. I think we have too many people that think they know what’s best, but in my experience, you allow individuals to make the choices they want to make. That’s their right. Regulations should be based on evidence and the FDA doesn’t have the evidence to say that vaping is a harmful product.”
The main purpose of the Cole-Bishop Amendment is to amend the February 15, 2007 grandfathered date set by the Tobacco Control Act for currently unregulated tobacco products, including nicotine containing electronic vaping devices and the e-liquid used in them. The Tobacco Control Act placed a requirement on these products to receive FDA marketing authorization – through either a Premarket Tobacco Application (PMTA) or Substantial Equivalence (SE) Report – before it can enter the market. The PMTA is a time consuming and expensive process, and unfortunately many vaping companies can’t afford that expense – especially when the process doesn’t guarantee approval.
“There is no scientific basis for forcing the vaping industry to jump through this many hoops,” said Congressman Cole. “There is a legitimate role the FDA plays for tobacco regulations, but e-cigarettes are not a tobacco product. They don’t have the same consequences for your health. I think the FDA got caught up in the hysteria over the declining use of tobacco products. The alternative to tobacco products is found in the vaping industry, and that’s good, not bad.”
This is why the Cole-Bishop Amendment is so important to the vaping industry. The Cole-Bishop Amendment will switch the grandfathered date to Aug. 8, 2016 – the effective date of the Deeming Regulation. The amendment would allow vaping products to avoid the lengthy and expensive PMTA process.
So, what can you do to ensure the amendment is passed?
“The most powerful thing to do is to meet with members of Congress and educate them,” said Congressman Cole. “A lot of the propaganda surrounding the vaping industry is negative and inaccurate. The best people to educate political leaders are their constituents. Believe me, when someone comes in that I represent, and they discuss their point of view, I make a point of listening and so does my staff. Availing yourself of the right as an American citizen to petition your government is the number one thing to do.”
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“I encourage people to explain to their congressman why we don’t need this kind of federal regulation, and what the consequences will be in terms of the manufacturing, selling and using the product for people who are in many cases trying to kick the tobacco habit,” said Congressman Cole. “We should be working to encourage it, not discourage it.”